Media: Press Releases

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Noven Pharmaceuticals, Inc., a wholly-owned subsidiary of Hisamitsu Pharmaceutical
Co., Inc., today announced that its New Drug Application (NDA) for low-dose
mesylate salt of paroxetine (7.5 mg) for the treatment of moderate to
severe vasomotor symptoms (hot flashes and night sweats) due to menopause
has been accepted for filing by the U.S. Food and Drug Administration
(FDA).

The acceptance of the NDA reflects the FDA’s determination that
the application is sufficiently complete to permit a substantive review.
The NDA has been assigned a Prescription Drug User Fee Act (PDUFA) action
date of June 28, 2013, which represents the goal date for the FDA to
complete its review of the NDA.

In addition, the FDA advised Noven that
the NDA for LDMP will be discussed at a meeting of the FDA’s Reproductive
Health Drugs Advisory Committee tentatively scheduled for March 4, 2013.

Low-dose mesylate salt of paroxetine (LDMP) is an investigational oral
nonhormonal therapy using 7.5 mg of paroxetine mesylate that was specifically
developed for the treatment of vasomotor symptoms due to menopause. Noven
submitted the LDMP NDA in August 2012.

About Noven
Noven Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged
in the research, development, manufacturing, marketing and sale of
prescription pharmaceutical products. Noven is committed to developing
and offering products and technologies that meaningfully benefit
patients, its customers and its industry partners. Noven is a stand-alone
operating subsidiary of Japan-based Hisamitsu Pharmaceutical Co.,
Inc., and serves as Hisamitsu's U.S. growth platform in prescription
pharmaceuticals. For more information about Noven, visit www.noven.com.
For information about Hisamitsu, visit www.global.hisamitsu.